The Role of Skin Microecology in Diabetic Skin Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNanfang Hospital, Southern Medical University
About this trial
This study is an observational study. Collect cotton swabs of the surface skin are obtained from the non-diabetic and diabetic patients hospitalized in the Nanfang Hospital of Southern Medical University. The investigators use omics technology to identify the structure and functions of cutaneous microbiome, analyze the characteristics of the skin flora of diabetic patients, and find the difference in skin microbiota among diabetic patients with different risk levels for developing into diabetic foot. Then, the participants will be followed up to compare the incidence of ulcers among different groups. And the skin tissues discarded during surgical operations of non-diabetic and diabetes patients are collected for pathological examination. Finally, based on the results of 16S high-throughput sequencing, metagenomics, etc., specific flora could be extracted from human skin flora cotton swabs, and animal experiments are performed to explore the effect of skin micro-ecology on diabetic skin lesions. The investigators will explore in animal experiments to regulate the influence of skin micro-ecology on diabetic skin lesions through treatment methods such as different hypoglycemic drugs and probiotic emulsions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Control subjects that was ruled out diabetes according to the WHO 1999 diagnostic criteria for euglycemia.
Age ≥18 years, the patient and (or) his family members know and agree to participate in this study.
The patient was diagnosed with type 2 diabetes in the Endocrinology Department, Burns Department, Traumatology Orthopedics, Plastic Surgery in Nanfang hospital.
Patients who need surgical operations such as debridement and amputation below the knee joint due to various reasons such as diabetic foot osteomyelitis, fractures, car accidents and so on.
Disqualifiers
None
Trial population
200 cases, 40 cases in each group
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 5 trial groupsGroup A: group ND
Group B: group VD
Group C: group LD
Group D: group MD
Group E: group HD
Trial outcomes
Primary outcomes
1
omics analysis of skin microbiome
Compared with non-diabetic patients, the differences in skin microbiome of diabetic patients with different disease progression.
Time frame
from September 2020 to July 20212
change of skin pathology in DM
The pathological changes of the skin tissues of diabetic patients with different disease progression.
Time frame
From August 2021 to July 20243
The incidence of developing into diabetic foot among the groups
Follow-up for 2 years to assess the impact of changes in the skin microecology of diabetic patients on the occurrence of diabetic foot ulcers
Time frame
From August 2023 to July 2025Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov